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PH12019501607A1 - Tapentadol nasal composition - Google Patents

Tapentadol nasal composition

Info

Publication number
PH12019501607A1
PH12019501607A1 PH12019501607A PH12019501607A PH12019501607A1 PH 12019501607 A1 PH12019501607 A1 PH 12019501607A1 PH 12019501607 A PH12019501607 A PH 12019501607A PH 12019501607 A PH12019501607 A PH 12019501607A PH 12019501607 A1 PH12019501607 A1 PH 12019501607A1
Authority
PH
Philippines
Prior art keywords
tapentadol
equivalent
human
pharmaceutically acceptable
acceptable salt
Prior art date
Application number
PH12019501607A
Inventor
Jaya Abraham
Vivek Mishra
Vipul Mittal
Kiran Chaudhari
Original Assignee
Torrent Pharmaceuticals Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Torrent Pharmaceuticals Ltd filed Critical Torrent Pharmaceuticals Ltd
Publication of PH12019501607A1 publication Critical patent/PH12019501607A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

An intranasal composition as unit dosage, comprising tapentadol or a pharmaceutically acceptable salt thereof in an amount that is equivalent to about 19.3 mg tapentadol free base; and at least one nasal carrier. After intranasal administration to the human a tapentadol mean Cmax-value achieved by said unit dose is equivalent to or greater than a tapentadol mean Cmax-value achieved by orally administering to the human an immediate release composition comprising tapentadol or a pharmaceutically acceptable salt thereof in an amount that is equivalent to 50 mg tapentadol free base.
PH12019501607A 2017-01-11 2019-07-09 Tapentadol nasal composition PH12019501607A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201721001203 2017-01-11
PCT/IB2018/050148 WO2018130948A1 (en) 2017-01-11 2018-01-10 Tapentadol nasal composition

Publications (1)

Publication Number Publication Date
PH12019501607A1 true PH12019501607A1 (en) 2020-03-09

Family

ID=61192975

Family Applications (1)

Application Number Title Priority Date Filing Date
PH12019501607A PH12019501607A1 (en) 2017-01-11 2019-07-09 Tapentadol nasal composition

Country Status (15)

Country Link
EP (1) EP3568126B1 (en)
CN (1) CN110191708A (en)
DK (1) DK3568126T3 (en)
ES (1) ES2968153T3 (en)
FI (1) FI3568126T3 (en)
HR (1) HRP20240030T1 (en)
HU (1) HUE065292T2 (en)
LT (1) LT3568126T (en)
PH (1) PH12019501607A1 (en)
PL (1) PL3568126T3 (en)
PT (1) PT3568126T (en)
RS (1) RS65027B1 (en)
SI (1) SI3568126T1 (en)
SM (1) SMT202400008T1 (en)
WO (1) WO2018130948A1 (en)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9202464D0 (en) 1992-02-05 1992-03-18 Danbiosyst Uk Composition for nasal administration
DE4426245A1 (en) 1994-07-23 1996-02-22 Gruenenthal Gmbh 1-phenyl-3-dimethylamino-propane compounds with pharmacological activity
US20040115133A1 (en) 2000-05-10 2004-06-17 Wermeling Daniel P. Intranasal opioid compositions
US20060110333A1 (en) 2002-07-11 2006-05-25 Taiho Pharmaceutical Co., Ltd. Composition for nasal absorption
GB0300531D0 (en) * 2003-01-10 2003-02-12 West Pharm Serv Drug Res Ltd Pharmaceutical compositions
WO2010100477A2 (en) 2009-03-03 2010-09-10 Shire Llc Amino acid and peptide carbamate prodrugs of tapentadol and uses thereof
US11413239B2 (en) 2011-07-20 2022-08-16 Torrent Pharmaceuticals Ltd. Pharmaceutical composition of tapentadol for nasal administration
CN103735500B (en) * 2014-01-28 2016-01-20 江苏华泽医药科技有限公司 Tapentadol hydrochloride injection and preparation method thereof
EP3777838A1 (en) * 2014-03-14 2021-02-17 Opiant Pharmaceuticals, Inc. Nasal drug products and methods of their use

Also Published As

Publication number Publication date
WO2018130948A9 (en) 2019-08-29
HUE065292T2 (en) 2024-05-28
LT3568126T (en) 2023-12-11
BR112019014408A2 (en) 2020-04-28
WO2018130948A1 (en) 2018-07-19
PL3568126T3 (en) 2024-03-25
DK3568126T3 (en) 2024-01-15
EP3568126B1 (en) 2023-11-01
CN110191708A (en) 2019-08-30
ES2968153T3 (en) 2024-05-08
SMT202400008T1 (en) 2024-03-13
FI3568126T3 (en) 2024-01-24
RS65027B1 (en) 2024-01-31
EP3568126A1 (en) 2019-11-20
PT3568126T (en) 2023-12-19
SI3568126T1 (en) 2024-03-29
HRP20240030T1 (en) 2024-03-29

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